(91 days)
According to 21 CFR, a patient examination glove is a disposable device intended for medical purpose that is worn on the examiner 's hand or finger to prevent contamination between patient and examiner.
PRE POWDERED LATEX PATIENT EXAMINATION GE
The provided text is a 510(k) premarket notification approval letter for a medical device: "PRE POWDERED LATEX PATIENT EXAMINATION GE" (likely "Glove"). This type of document is a regulatory approval, not a scientific study report. It states that the device is "substantially equivalent" to legally marketed predicate devices.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The information requested (such as sample size, ground truth, expert qualifications, adjudication methods, and details of standalone or MRMC studies) is typically found in clinical trial reports or detailed performance studies, which are not part of this 510(k) approval letter.
The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device, which is what this letter confirms. However, specific performance metrics and a study to prove they are met are not detailed here.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.